NCT01983085: ProNOx2

ProNOx 2 - A Clinical Study of Superficial Partial Thickness Wound Treatment With an Oxides of Nitrogen Generating Gel Dressing

Terminated Phase 2 Last updated 12 April 2021

What this trial tests

Phase 2 trial testing NOx dressing in Superficial Partial Thickness Burn in 13 participants. Terminated before completion.

Timeline

1 September 2013

Primary endpoint
1 March 2014

1 May 2014

Quick facts

Lead sponsor	Edixomed Ltd
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 September 2013
Primary completion	1 March 2014
Estimated completion	1 May 2014
Sites	2 locations across United Kingdom

Drugs / interventions tested

• NOx dressing
• Standard of Care

Conditions studied

• Superficial Partial Thickness Burn — all drugs for Superficial Partial Thickness Burn →
• Skin Graft; Complications — all drugs for Skin Graft; Complications →

Sponsor

Edixomed Ltd

Who can join

1 and older, any sex, with Superficial Partial Thickness Burn or Skin Graft; Complications. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Average number of days until healing (defined as 95% epithelisation) in SPT wounds treated with conventional Mepitel® dressing vs. investigational nitric oxide generating gel dressing
  Time frame: From randomisation and first application of the dressing, patients are assessed every 2 days until 95% epithelialisation occurs

Sponsor's own description

This is a study to assess the safety and efficacy of a nitric oxide (NOx) generating dressing on superficial partial thickness (SPT) wounds. Nitric oxide has a range of effects on the body including vasodilation and angiogenesis. It is also a potent antimicrobial. This 160 patient, randomised, controlled clinical study will assess the ability of a simple 2 part, NOx generating dressing to improve healing in SPT burn wounds and SPT skin graft donor site wounds compared to standard of care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Gasotransmitters in Modern Medicine: Promises and Challenges in the Use of Porous Crystalline Carriers.
   Pinto RV, Pinto ML, Serre C. · · 2025 · cited 7× · PMID 40059496 · DOI 10.1002/adhm.202404553